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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P160048 S006/ PAS001 |
| Date Original Protocol Accepted |
11/25/2019
|
| Date Current Protocol Accepted |
03/27/2025
|
| Study Name |
Eversense CGM Non-Adjunctive PAS
|
| Device Name |
Eversense Continuous Glucose Monitoring System
|
| Clinical Trial Number(s) |
NCT02647905
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the P160048/S018 PAS is to demonstrate the long-term safety and effectiveness of the Eversense System
when used non-adjunctively. The investigation will include both use of self-monitoring of blood glucose (SMBG) and
either the Eversense CGM System, the Eversense E3 CGM System, or the Eversense 365 CGM System. The study will
evaluate the effectiveness of SMBG for diabetes management decisions compared to Eversense System used non-adjunctive
in study participants with either Type 1 or Type 2 diabetes.
Subjects will serve as their own baseline using SMBG for the first 6 months followed by using the Eversense System nonadjunctively for the second six months, when enrolled with the Eversense or Eversense E3 CGM Systems. Subjects receiving the Eversense 365 CGM System at enrollment will be enrolled
directly into the non-adjunctive phase of the study. All care decisions specific to diabetes to be based on blood glucose
values in the first phase and the CGM system value in the second phase. Thus, this non-blinded, prospective, multicenter, single arm longitudinal cohort study (patient serves as
their own control) will evaluate safety and effectiveness of the Eversense CGM System used non-adjunctively in the postmarket setting.
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| Study Population |
Subjects may be included in the PAS if they fit the following inclusion criteria:
1. Subject has diabetes
2. Subject is greater than or equal to 18 years of age
3. Subject has a smartphone that is internet enabled
4. Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator’s opinion
5. Subjects is willing and able to provide written, signed and dated informed consent
Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
1. Subject is critically ill or hospitalized
2. Prior use of Eversense CGM systems
3. Subject has a known contraindication to dexamethasone or dexamethasone acetate
4. Subjects requiring intravenous mannitol or mannitol irrigation solutions
5. Subject is on dialysis at the time of enrollment
6. Female subjects who are pregnant, planning on becoming pregnant or nursing
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| Sample Size |
Up to 925 subjects will be enrolled in the United States at up to 60 sites.
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| Key Study Endpoints |
The primary safety endpoint is the rate of the composite of severe hypoglycemia and diabetic ketoacidosis.
Other safety endpoints include:
Rate of all device-related and insertion and removal procedure-related adverse events
Rate of adverse events related to use of the user interface, patient training, or labeling materials.
Change in HbA1c from baseline at 6 and 12 months
Average hours of use per day
Serious adverse events regardless of causality
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| Follow-up Visits and Length of Follow-up |
Every 4 weeks (phone visits). Subjects who receive the Eversense 365 CGM System will participate for 12 months non-adjunctively.
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
For Post-Approval Study (P160048): Three hundred thirty-four (334) adverse events (AE) have been reported as of the reporting period through April 10, 2023. Of these events, 93 are related to the study device and/or the insertion or removal procedure.
For Eversense CGM Non-Adjunctive PAS (P160048/S006):
One hundred fifty (150) adverse events (AEs) have
been reported as of the reporting period through 01
May 2025. One hundred forty-five (145) of these
events have complete adjudication by CEC members.
Of the 145 total adverse events that have been
adjudicated, 74 events were adjudicated as Serious
Adverse Events (SAE), with none related to the
device. Thirty-six (36) device malfunctions have
been reported to date. Eleven (11) of the reported
device malfunctions are documented as related to the
Sensor. Of those 11, eight (8) are documented as
early Sensor retirement (1.3%). The percent of early
Sensor retirements is consistent with the PRECISE II
study results, wherein 91% of Sensors remained
functioning through 90 days, with the PROMISE
study results, wherein 90% of Eversense E3 Sensors
remained functioning through 180 days, and with the
ENHANCE study results, wherein 90% of Eversense 365 Sensors remained functioning through 12 months.
Effectiveness Results
For Post-Approval Study (P160048): Effectiveness data will be presented once the primary endpoint of the study is reached at 12 months following the completion of all insertions.
For Eversense CGM Non-Adjunctive PAS (P160048/S006):
Effectiveness data will be based on data from all enrolled subjects who have data evaluable.
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| Actual Number of Patients Enrolled |
For P160048: 273
For P160048/S006: 664
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| Actual Number of Sites Enrolled |
For P160048 (Adjunctive Use): 6
For P160048/S006 (Non-Adjunctive Use): 25
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| Patient Follow-up Rate |
For P160048: 97.4% (266/273)
For P160048/S006:
53 out of 661 lost to follow-up; One hundred eighty
(180) subjects have discontinued their participation in
the study. One hundred twenty-seven (127) of the
180 withdrew and 53 of the 180 are documented as
lost to follow-up. Prior to these subjects being
designated as loss to follow-up, the sites attempted
contact multiple times by phone and email which was
then followed by a registered letter requesting the
subject contact the site.
Of the 127 subjects who withdrew, 87 were in Phase
1 and did not have a Sensor inserted and 40 of the
subjects were in Phase 2. Forty-nine (49) of the 53
subjects who wee lost to follow-up were in Phase 1
and did not have a Sensor inserted and 4 of the
subjects were in Phase 2 and have not had the Sensor
removed as of the date of this report to the best of
Sponsor's knowledge.
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